Blog
RSS FeedPosted by Michael Wonder on 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...
Posted by Michael Wonder on 16 Apr 2018
Provisional approval pathway - first determination decision
16 April 2018 - Olaratumab (Lartruvo) is the first medicine to be granted a provisional approval determination under the new ...
Posted by Michael Wonder on 06 Apr 2018
MorphoSys announces approvals for Tremfya (guselkumab) for the treatment of moderate-to-severe plaque psoriasis in Brazil and Australia
5 April 2018 - MorphoSys announced today that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been ...
Posted by Michael Wonder on 05 Apr 2018
Specialised Therapeutics initiates early access program for neratinib maleate
5 April 2018 - Specialised Therapeutics today announces the initiation of an early access program for neratinib maleate an extended ...
Posted by Michael Wonder on 03 Apr 2018
Half yearly performance snapshot: July to December 2017
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 20 Mar 2018
Provisional approval pathway: prescription medicines
20 March 2018 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation, the TGA ...
Posted by Michael Wonder on 15 Mar 2018
Product withdrawn after overseas reports of inflammatory brain disorders
15 March 2018 - Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw ...
Posted by Michael Wonder on 22 Feb 2018
Biosimilar medicines regulation
22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the ...
Posted by Michael Wonder on 21 Feb 2018
Mandatory requirements for an effective application
21 February 2018 - Applicable for applications lodged from 9 February 2018. ...
Posted by Michael Wonder on 13 Feb 2018
All TGA approvals for prescription medicines in 2017 met the statutory timeframe of 255 working days
9 February 2018 - A recent media report suggesting that half of TGA approvals for prescription medicines in 2017 exceeded ...
Posted by Michael Wonder on 07 Feb 2018
Priority review pathway - first registration decision
6 February 2018 - Alectinib hydrochloride (Alecensa) is the first medicine to be registered on the Australian Register of Therapeutic ...
Posted by Michael Wonder on 01 Feb 2018
TGA approves first Humira biosimilar
1 February 2018 - Hadlima was registered by the TGA on 24 January 2018. ...
Posted by Michael Wonder on 30 Jan 2018
Transforming health care through precision medicine
31 January 2018 - Lately we've both been enjoying ITV's drama Victoria. By all accounts Queen Victoria lived well, dying ...
Posted by Michael Wonder on 30 Jan 2018
Prescription medicines and biologicals: TGA annual summary 2017
30 January 2018 - This is TGA's fourth annual summary report on the registration of prescription medicines, which includes new generic ...